title: Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia.
abstract: OBJECTIVE
  Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5α-reductase inhibitor monotherapy or coadministration with an α-blocker. We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms.
  
  
  METHODS
  In an international, randomized, double-blind, parallel study of men 45 years old or older who were 5α-reductase inhibitor naïve and had an I-PSS (International Prostate Symptom Score) of 13 or greater and prostate volume 30 ml or greater, 350 were treated with placebo/finasteride and 345 received tadalafil/finasteride for 26 weeks. Changes in lower urinary tract symptoms secondary to benign prostatic hyperplasia were assessed with the I-PSS, erectile dysfunction improvements were assessed with the IIEF-EF (International Index of Erectile Function-Erectile Function) in sexually active men and safety was assessed by evaluating adverse events.
  
  
  RESULTS
  Least squares mean changes from baseline in I-PSS after 4, 12 and 26 weeks of tadalafil/finasteride coadministration were -4.0, -5.2 and -5.5, respectively. Corresponding values for placebo/finasteride coadministration were -2.3, -3.8 and -4.5 (p ≤ 0.022 at all visits favoring tadalafil/finasteride coadministration). I-PSS subscores (storage and voiding) and quality of life index were also numerically improved with tadalafil/finasteride coadministration. Least squares mean changes from baseline in IIEF-EF with tadalafil/finasteride coadministration were 3.7 after 4 weeks, and 4.7 after 12 and 26 weeks. Corresponding values for placebo/finasteride coadministration were -1.1, 0.6 and -0.0 (p <0.001 at all visits favoring tadalafil/finasteride coadministration). Tadalafil/finasteride coadministration was well tolerated and most adverse events were mild/moderate.
  
  
  CONCLUSIONS
  The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement. Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction.
authors.affiliation: Instituto Médico Especializado, Buenos Aires, Argentina.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Casabé
authors.affiliation: University of Texas Southwestern Medical Center, Dallas, Texas.
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.affiliation: Department of Urology, Ospedale Papa Giovanni XXIII-Bergamo, Bergamo, Italy.
authors.forename: Luigi F
authors.initials: LF
authors.lastname: Da Pozzo
authors.affiliation: Saltillo University Hospital, Saltillo, Mexico.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Zepeda
authors.affiliation: Regional Urology LLC, Shreveport, Louisiana.
authors.forename: R Jonathan
authors.initials: RJ
authors.lastname: Henderson
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Sorsaburu
authors.affiliation: Global Statistical Sciences, Lilly Deutschland GmbH, Bad Homburg, Germany.
authors.forename: Carsten
authors.initials: C
authors.lastname: Henneges
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: David G
authors.initials: DG
authors.lastname: Wong
authors.affiliation: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana. Electronic address: viktrup_lars@lilly.com.
authors.forename: Lars
authors.initials: L
authors.lastname: Viktrup
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002243:Carbolines / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D018120:Finasteride / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D000068581:Tadalafil; D016896:Treatment Outcome; D064804:Urological Agents / Q000627:therapeutic use*
chemical_list: D002243:Carbolines; D064804:Urological Agents; D018120:Finasteride; D000068581:Tadalafil
keywords: erectile dysfunction; finasteride; lower urinary tract symptoms; prostatic hyperplasia; tadalafil